Stents, valved-stents and methods and systems for delivery thereof

ABSTRACT

Embodiments of the present disclosure are directed to stents, valved-stents, (e.g., single-stent-valves and double stent/valved-stent systems) and associated methods and systems for their delivery via minimally-invasive surgery. The stent component comprises a first stent section ( 102 ) a second stent section ( 104 ) a third stent section ( 106 ) and a fourth stent section ( 108 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.12/739,117, filed Apr. 21, 2010, which is a 35 U.S.C. §371 nationalstage entry of PCT/EP2008/064558 which has an international filing dateof Oct. 27, 2008 and claims priority to U.S. Provisional ApplicationNos. 61/000,587 filed Oct. 25, 2007; 61/067,189 filed Feb. 25, 2008, and61/052,560, filed May 12, 2008, each disclosure of which in theirentirety, is herein incorporated by reference.

FIELD OF THE DISCLOSURE

Embodiments of the present disclosure are directed to systems, methods,and devices for cardiac valve replacement in mammalian hearts.

BACKGROUND OF THE DISCLOSURE

Conventional approaches for cardiac valve replacement require thecutting of a relatively large opening in the patient's sternum(“sternotomy”) or thoracic cavity (“thoracotomy”) in order to allow thesurgeon to access the patient's heart. Additionally, these approachesrequire arrest of the patient's heart and a cardiopulmonary bypass(i.e., use of a heart-lung bypass machine to oxygenate and circulate thepatient's blood). In recent years, efforts have been made to establish aless invasive cardiac valve replacement procedure, by delivering andimplanting a cardiac replacement valve via a catheter percutaneously(i.e., through the skin) via either a transvascular approach—deliveringthe new valve through the femoral artery, or by transapical route, wherethe replacement valve is delivered between ribs and directly through thewall of the heart to the implantation site.

While less invasive and arguably less complicated, percutaneous heartvalve replacement therapies (PHVT) still have various shortcomings,including the inability for a surgeon to ensure proper positioning andstability of the replacement valve within the patient's body.Specifically, if the replacement valve is not placed in the properposition relative to the implantation site, it can lead to poorfunctioning of the valve. For example, in an aortic valve replacement,if the replacement valve is placed too high, it can lead to valveregurgitation, instability, valve prolapse and/or coronary occlusion. Ifthe valve is placed too low, it can also lead to regurgitation andmitral valve interaction.

To address such risks, recapture procedures and systems have beendeveloped. For example, such a system is disclosed in U.S. publicationno. 20050137688 and U.S. Pat. No. 5,957.949, each disclosure of which isherein incorporated by reference. While such systems may address theproblem of improper placement, they are somewhat complicated, requiringthe use of wires which are removable attached to an end of the stent topull the stent back into the delivery catheter.

Throughout this description, including the foregoing description ofrelated art, any and all publicly available documents described herein,including any and all U.S. patents, are specifically incorporated byreference herein in their entirety. The foregoing description of relatedart is not intended in any way as an admission that any of the documentsdescribed therein, including pending United States patent applications,are prior art to embodiments according to the present disclosure.Moreover, the description herein of any disadvantages associated withthe described products, methods, and/or apparatus, is not intended tolimit inventions disclosed herein. Indeed, aspects of the disclosedembodiments may include certain features of the described products,methods, and/or apparatus without suffering from their describeddisadvantages.

SUMMARY OF THE DISCLOSURE

In some embodiments, a replacement valve for use within a human body isprovided, where the replacement valve includes a valve component and astent component (the replacement valve also being referred to as avalved-stent or a stent valve, and may he used interchangeably withreplacement valve throughout the disclosure). The stent componentdefines a first (e.g., proximal) end and a second (e.g., distal) end andmay include a plurality of stent section, and in some embodiments, atleast four stent sections. The proximal end P of the stent component maybe described as the end of the stent component/replacement valve whichultimately is positioned adjacent and/or within the left ventricle.Alternatively, the proximal end P of the stent component may bedescribed as the end having anchoring elements for attachment to thedelivery catheter (e.g., attachment end in a transapical deliverysystem). The distal end D of the stent component may be described as theend of the replacement valve/stent component which ultimately ispositioned adjacent and/or near the ascending aorta, when, for example,the delivery catheter is advanced toward/into the ascending aorta in atransapical delivery system. According to preferred embodiments of thedisclosure, the replacement valves according to at least someembodiments are released distal-to-proximal, that is, the end of thestent (replacement valve) which ultimately is positionedwithin/near/adjacent the aorta is released first, and the end of thestent (replacement valve) which ultimate is positionedwithin/near/adjacent the ventricle is released last. Such a delivery,according to preferred embodiments, is via a transapical approach, orthrough the heart muscle (as opposed to being deliveredtransvascularly). While preferred embodiments disclosed herein aredescribed as being delivered through a direct heart access approach(e.g., transapical approach using transapical/direct access deliverysystems), some embodiments of the present invention may be deliveredtransvascularly.

The first stent section may define an at least partly conical body andthe first end of the stent component. The conical body of the firststent section may slope outwardly in the direction of the first end. Insome embodiments, the first stent section may include at least oneattachment element for removable attachment to a delivery device.

The second stent section may be in communication with the first stentsection and may define an at least partly conical body. The conical bodyof the second stent section may slope outwardly in the direction of thesecond end.

The third stent section may be in communication with the second stentsection and may define an at least partially cylindrical body. The thirdstent section may be configured to house at least a portion of the valvecomponent. The third stent section may include a plurality of arches forfixation to a corresponding plurality of commissures of the valvecomponent.

The fourth stent section may be in communication with the third stentsection and may define the second end. The fourth stent section mayfurther define an at least partly conical body, which may slopeoutwardly in the direction of the second end. The fourth stent sectionmay include a plurality of arches larger than, but aligned with, theplurality of arches included in the third stent section.

The four stent sections may be formed, for example, by laser cutting atube or single sheet of material (e.g., nitinol). For example, the stentmay be cut from a tube and then step-by-step expanded up to its finaldiameter by heat treatment on a mandrel. As another example, the stentmay be cut from a single sheet of material, and then subsequently rolledand welded to the desired diameter.

In some embodiments of the present disclosure, a stent component may beprovided that includes a central, longitudinal axis and at least oneattachment element for removable attachment to a delivery device. The atleast one attachment element may be formed generally in the shape of ahook extending inwardly towards the central, longitudinal axis. Thedelivery device may include a stent holder comprising a groove forreceiving the attachment element of the stent component, wherein releaseof the stent- valve from the stent holder may be facilitated by rotationof the stent holder relative to the attachment element.

In still other embodiments of the present disclosure, a replacementvalve for use within a human body is provided that includes a valvecomponent, a stent component for housing the valve component, and atleast two skirts (e.g., polyester (PET) skirts). An inner skirt may beprovided that covers at least a portion (e.g., all) of an outer surfaceof the valve component, where the inner skirt may be sutured to at leastthe inflow tract of the valve component and to an inner surface of thestent. An outer skirt may also be provided that is sutured onto an outersurface of the stent.

Some embodiments of the present disclosure provide a cardiac stent-valvedelivery system that includes an inner assembly and an outer assembly.The inner assembly may include a guide wire lumen (e.g., polymerictubing) and a stent holder for removable attachment to a stent-valve.The outer assembly may include a sheath. The inner member and the outermember may be co-axially positioned and slidable relative to one anotherin order to transition from a closed position to an open position, suchthat in the closed position the sheath encompasses the stent-valve stillattached to the stent holder and thus constrains expansion of thestent-valve. In the open position, the outer sheath may not constrainexpansion of the stent-valve and thus the stent-valve may detach fromthe stent holder and expand to a fully expanded configuration.

In some embodiments, the inner assembly of the delivery device mayinclude a fluoroscopic marker fixed to the guide wire lumen distal ofthe stent holder.

In some embodiments, the diameter of the outer assembly of the deliverydevice varies over its longitudinal axis.

In still other embodiments, the delivery system comprises a rigid (e.g.,stainless steel) shaft in communication with a proximal end of the guidewire lumen.

In some embodiments, the delivery system comprises a luer connector incommunication with the rigid shaft.

In some embodiments of the present disclosure, a method is provided forreplacing an aortic valve within a human body. A stent-valve may becovered with a sheath in order to maintain the stent-valve in acollapsed configuration. The stent-valve may then may be inserted in thecollapsed configuration into the human body without contacting theascending aorta or aortic arch. The stent-valve may be partiallyexpanded by sliding the sheath towards the left ventricle of the heart.This sliding of the sheath towards the left ventricle may causeexpansion of a distal end of the stent-valve while the proximal end ofthe stent-valve remains constrained by the sheath. The sheath may befurther slid towards the left ventricle of the heart in order to causefull expansion of the stent-valve. In some embodiments, the stent-valvemay be recaptured prior to its full expansion by sliding the sheath inthe opposite direction.

In some embodiments, a method for cardiac valve replacement is providedthat includes releasing a distal end of a stent-valve from a sheath,where the distal end includes a radiopaque marker positioned thereon.The stent-valve is rotated, if necessary, to orient the stent-valveappropriately with respect to the coronary arteries (e.g., to preventthe commissures from facing the coronary arteries). Arches of thestent-valve are released from the sheath, in order to cause the archesto contact the aorta. A first conical crown of the stent-valve isreleased from the sheath, in order to cause the first conical crown tocontact the native valve leaflets. A second crown of the stent-valve isreleased from the sheath, in order to cause the second crown to contactan annulus/inflow tract. The second crown may be the proximal section ofthe stent-valve such that releasing the second crown causes thestent-valve to be fully released from the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the embodiments of the present disclosure,reference is made to the following description, taken in conjunctionwith the accompanying drawings, in which like reference characters referto like parts throughout, and in which:

FIG. 1A is a side view of a stent component configured fordistal-to-proximal expansion according to some embodiments of thepresent disclosure.

FIG. 1B shows the placement of a double polyester (PET) fabric skirt(dashed line representing inner PET fabric skirt 122 and outer PETfabric skirt 126) relative to a stent component, as well as placement ofa valve-component within the stent (e.g., aortic biologic valveprosthesis, dashed line 124).

FIG. 2A shows an unrolled, flat depiction of another embodiment of astent component according to some embodiments of the present disclosure.

FIG. 2B is a side view of a stent component shown in FIG. 2A.

FIG. 3A show a stent design with longitudinal elements for commissuralvalve fixation.

FIG. 3B shows an unrolled, flat depiction of the stent design of FIG.3A.

FIG. 4 shows an unrolled, flat depiction of an alternative design basedon similar embodiments, without reinforcement crown,

FIG. 5 and FIG. 6 show the size and shape of the anchoring crowns forthe stent component in the expanded configuration according to someembodiments of the disclosure.

FIG. 7 shows the size and shape of stabilization arches for the stentcomponent in the expanded configuration according to some embodiments ofthe disclosure.

FIG. 8 shows a mating couple between attachment elements of the stentcomponent and a stent-holder of a delivery device, according to someembodiments of the present disclosure.

FIG. 9 shows the design of multiple fixation elements (e.g., “holes”)that allow for the fixation of the stent onto the catheter when thestent is crimped or in the collapsed configuration.

FIG. 10 shows the tip of the elements forming the anchoring crown, whichmay be bent towards the longitudinal axis of the stent thereby avoidingpotential injury, such as injury to the sinus of vasalva duringimplantation of the device.

FIG. 11A shows an embodiment of the present disclosure, wherein thestabilization arches are designed to be independent of the valvefixation devices.

FIG. 11B shows an embodiment of the present disclosure, wherein thestabilization arches are designed with gradual stiffness change andconnected to valve fixation arches.

FIG. 12 illustrates a placement of a double polyester (PET) fabric skirtrelative to a stent component, according to some embodiments of thepresent disclosure.

FIG. 13 shows the in vivo migration of a stent according to the presentdisclosure, wherein the design of the stent allows for aself-positioning under diastolic pressure.

FIG. 14A shows a delivery system for distal-to-proximal expansion of astent-valve, according to some embodiments of the present disclosure.

FIG. 14B shows the size and shape of delivery system according to someembodiments.

FIGS. 15A-D illustrate a method of implanting a stent-valve within ahuman heart according to some embodiments of the present disclosure.

FIGS. 16A-D illustrate the partial release of a stent according to thepresent disclosure, the release of which is stopped by a security tab.

FIGS. 17A-D illustrate the capture of the stent after partial releaseaccording to FIG. 16.

FIGS. 1 8A-C illustrate the full release of a stent according to someembodiments of the present disclosure.

DETAILED DESCRIPTION

Some embodiments of the present disclosure are directed to systems,methods, and devices for cardiac valve replacement. For example, suchmethods, systems, and devices may be applicable to the full range ofcardiac-valve therapies including, for example, replacement of failedaortic, mitral, tricuspid, and pulmonary valves. Some embodiments mayfacilitate a surgical approach on a beating heart without the need foran open-chest cavity and heart-lung bypass. This minimally-invasivesurgical approach may reduce the risks associated with replacing afailed native valve in the first instance, as well as the risksassociated with secondary or subsequent surgeries to replace failedartificial (e.g., biological or synthetic) valves.

Stents, Stent-Valves/Valved-Stents

Some embodiments of the present disclosure relate to stents andstent-valves or valved-stents. Valved-stents according to someembodiments of the present disclosure may include a valve component andat least one stent component (e.g., a single-stent-valve or adouble-stent-valve). The valve component may include a biological valve(e.g., bovine harvested valve), a synthetic valve (e.g., eithersynthetic valve leaflet material and/or a mechanical valve assembly),any other suitable material(s). The stent and valve components accordingto some embodiments may be capable of at least two configurations: acollapsed or contracted configuration (e.g., during delivery) and anexpanded configuration (e.g., after implantation).

According to some embodiments, the valved-stent or stent-valves of thepresent disclosure may be used as replacement heart valves and may beused in methods for replacing diseased or damaged heart valves. Heartvalves are passive structures that simply open and close in response todifferential pressures on either side of the particular valve. Heartvalve comprise moveable “leaflets” that open and close in response todifferential pressures on either side of the valve's leaflets. Themitral valve has two leaflets and the tricuspid valve has three. Theaortic and pulmonary valves are referred to as “semilunar valves” due tothe unique appearance of their leaflets or “cusps” and are shapedsomewhat like a half-moon. The aortic and pulmonary valves each havethree cusps.

The valve component is preferably designed to be flexible, compressible,host-compatible, and non-thrombogenic. The valve component can be madefrom various materials, for example, fresh, cryopreserved orglutaraldehyde fixed allografts or xenografts. Synthetic biocompatiblematerials such as polytetrafluoroethylene, polyester, polyurethane,nitinol or other alloy/metal foil sheet material and the like may beused. The preferred material for the valve component is mammalpericardium tissue, particularly juvenile-age animal pericardium tissue.

The valve component can be any replacement heart valve known or used andcardiac replacement valves. Replacement heart valves arc generallycategorized into one of three categories: artificial mechanical valves;transplanted valves; and tissue valves. Mechanical valves are typicallyconstructed from nonbiological materials such as plastics, metals, andother artificial materials. Transplanted valves are natural valves takenfrom cadavers. These valves are typically removed and frozen in liquidnitrogen, and are stored for later use. They are typically fixed inglutaraldehyde to eliminate antigenicity. Artificial tissue valves arevalves constructed from animal tissue, such as bovine or porcine tissue.Efforts have also been made at using tissue from the patient for whichthe valve will be constructed. Such regenerative valves may also me usedin combination with the stent components described herein. The choice ofwhich type of replacement heart valves are generally based on thefollowing considerations: hemodynamic performance, thrombogenicity,durability, and ease of surgical implantation.

Most tissue valves are constructed by sewing the leaflets of pig aorticvalves to a stent to hold the leaflets in proper position, or byconstructing valve leaflets from the pericardial sac of cows or pigs andsewing them to a stent. See e.g., U.S. Patent Publication No.2005/0113910, the disclosure of which is herein incorporated byreference in its entirety. Methods of creating artificial tissue valvesis described in U.S. Pat. Nos. 5,163,955, 5,571,174, and 5,653,749, thedisclosures of which are herein incorporated by reference in theirentireties.

According to some embodiment, the valve component is preferably attachedto the inner channel of the stent member. This may be accomplished usingany means known in the art. Preferably, the valve component ispreferably attached to the inner channel of the stent member by sutureor stitch, for example, by suturing the outer surface of the valvecomponent pericardium material to the stent member. Preferably, thethird stent section may be configured to house at least a portion of thevalve component. Other fixation schemes can also be utilized. Theattachment position of the valve is preferably closer to the proximalend of the stent chosen with the understanding that the annulus of thevalve will preferably engage the outer surface of the stent at thegroove (see FIG. 15D; 1560) created at the junction between the firstand second sections of the stent component.

The stent component defines a first (e.g., proximal) end and a second(e.g., distal) end and includes at least four stent sections: a proximalconically shaped first section; a conically shaped second section; anoptional cylindrically shaped third section; and a distal conicallyshaped forth section.

The first stent section may define an at least partly conical body andthe first end of the stent component. The conical body of the firststent section may slope outwardly in the direction of the first end. Forexample, FIG. 2 shows a conically shaped first section 202 with ananchoring crown towards the ascending aorta. In some embodiments, thefirst stent section may include at least one attachment element forremovable attachment to a delivery device.

The second stent section may be in communication with the first stentsection and may define an at least partly conical body. The conical bodyof the second stent section may slope outwardly in the direction of thesecond end. For example, FIG. 2 shows a conically shaped second section204 with an anchoring crown towards the left ventricle, or in thedirection of blood flow (see e.g., FIG. 1).

The radial force of this section may be increased by adjusting thelength and angle (i.e., increased length H1 and angle α1; see FIG. 5) ofthe stent struts to reduce the risk of migration towards the leftventricle. In some embodiments, the tip of the elements forming theanchoring crown may be bent towards the longitudinal axis of the stentthereby avoiding potential injury of the sinus of vasalva (see e.g.,FIG. 10).

The third stent section may be in communication with the second stentsection and may define an at least partially cylindrical body. The thirdstent section may be configured to house at least a portion of the valvecomponent. The third stent section may include a plurality of arches forfixation to a corresponding plurality of commissures of the valvecomponent. For example, FIG. 2 shows a cylindrical third section 206which acts as a reinforcement crown.

The free area between the three valve fixation arches may be adjusted(i.e., increased or decreased) to improve the blood flow to the coronaryarteries. This section of the stent may be attached to the previousanchoring crown (conically shaped section no 2) at three positions (seee.g., FIG. 11). This may allow for the out of plane bending of theelements of the section no 2 to form the conical shape.

The fourth stent section may be in communication with the third stentsection and may define the second end. The fourth stent section mayfurther define an at least partly conical body, which may slopeoutwardly in the direction of the second end. The fourth stent sectionmay include a plurality of arches larger than, but aligned axiallyand/or circumferentially with, the plurality of arches included in thethird stent section.

Stabilization arches may be provided within the ascending aorta thatwork independently of the valve fixation arches. Variations of theascending aorta diameter may therefore have no impact on the valvefixation arches and thus on the valve haemodynamic properties.Furthermore, in some embodiments, stabilization arches may be providedthat are connected to the valve fixation arches in order to increase thefree area between the three valve fixation arches and thus improve theblood flow to the coronary arteries. The specific design of thestabilization arches with a gradual stiffness change allows thestabilization arches to work independently of the valve fixation arches(see e.g., FIG. 11). The three stabilization arches may reinforce inthis configuration the three valve fixation arches and thus reduce theirdeflection towards the longitudinal axis of the stent under diastolicpressure. Thus, according to some embodiments of the present disclosure,the stabilization arches may be designed to be independent of the valvefixation devices. See FIG. 11A. According to some embodiments of thepresent disclosure, the stabilization arches may be designed withgradual stiffness change and connected to valve fixation arches. SeeFIG. 11B.

These four stent sections may be formed, for example, by laser cutting atube or single sheet of material (e.g., nitinol). For example, the stentmay be cut from a tube and then step-by-step expanded up to its finaldiameter by heat treatment on a mandrel. As another example, the stentmay be cut from a single sheet of material, and then subsequently rolledand welded to the desired diameter.

FIG. 1A is a side view of a stent component 100 for supporting areplacement valve, according to some embodiments of the presentdisclosure, which is generally symmetrical in the vertical plane about alongitudinal axis 101. The stent component may be self-expanding and/ormay be expanded via, for example, a balloon. Such stents may be formedfrom a suitable material familiar to those of skill in the art, whichmay include, for example, stainless steel or a shape-memory material(e.g., nitinol) or a combination of materials. In some embodiments, thestent component may be laser cut from a single tube or sheet of suchmaterial(s).

As shown in FIG. 1A, the stent component may comprise a plurality ofsections. For example, such a stent may comprise four sections: 102,104, 106, 108). Stent section 102, for example, may define a proximalend of the stent component. In some embodiments of the presentdisclosure, stent section 102 may be generally conically shaped, andrepresent a section of a cone (e.g., a truncated cone, frustrum, etc.),having a first plane of a first smaller diameter, and a second planespaced apart from the first plane and having a second larger diameterthan the first diameter. In some embodiments, the two planes may beparallel.

According to some embodiments, stent section 102 has a shape and sizeconfigured such that it may create a form fit with one side (e.g., theinflow side) of the cardiac valve being replaced (e.g., aortic valve),for example, and therefore prevent migration of the valved-stent. If thestent is used in an aortic valve replacement, the fit of section 102that prevents (or substantially prevents) migration of the valved-stenttowards the ascending aorta (or prevents migration of the stentcomponent if the stent is used as a positioning stent for receiving asecond stent having the valve component). Furthermore, section 102 mayprovide a radial force, for example, that creates an additional frictionfit against the inflow tract/aortic annulus.

The second stent section 104 also may also have a generally conicalshape, according to some embodiments, and like section 102, mayrepresent a section of a cone (e.g., a truncated cone, a frustrum, etc.)having a first plane of a first smaller diameter, and a second planespaced apart from the first plane and having a second larger diameterthan the first diameter. In some embodiments, the two planes may beparallel. Blood flow may be in the direction shown in FIG. 1A by arrow110.

In some embodiments, the first planes of section 102 and section 104,having the smaller radii, match (or substantially match) and lieimmediately adjacent one another, and may be joined thereto as well.Thus, such an arrangement may correspond to two inverted frustrums.According to some embodiments, stent section 104 has a size and shapeconfigured such that it may create a form fit with a second tract of thevalve being replaced (e.g., the outflow tract/native leaflets of theaortic valve). If the stent is used for an aortic valve replacement, thefit of section 104 may prevent (or substantially prevent) migration ofthe valved-stent towards the left ventricle (or mayprevent/substantially prevent migration of the stent component if thestent is used as a positioning stent for receiving a second stent havingthe valve component). Furthermore, stent section 104 may also provide aradial force that creates an additional friction fit against the valveannulus (e.g., aortic annulus/outflow tract/native leaflets, for example(e.g., an aortic valve replacement).

The third stent section 106, which may overlap with stent section 104,and may also have a generally conical shape, according to someembodiments, but in other embodiments, a substantial portion or all ofsection 106 preferably more cylindrical in shape. Section 106 preferablydesignates the portion of the stent component to which the valvecomponent/prosthesis may be affixed onto the stent component. Accordingto some embodiments, stent section 106 may comprise a plurality of(e.g., two, three, four, five, six, eight, etc.) arches which may beused, for example, for the fixation of the valve commissures. In someembodiments, one or more of the arches may also comprise additionalreinforcements for fixation of the valve prosthesis.

The fourth stent section 108, according to some embodiments, may definea distal end of the stent component. In some embodiments, stent section108 may have a generally conical shape, with the slant height of theconical shape oriented at an angle having a direction which maycorrespond to a direction of the angle of the slant height of stentsection 104. In some embodiments, stent section 108 may comprise aplurality of (e.g., two, three, four, five, six, eight, etc.) arches,which may be larger than the arches noted for section 106, where sucharches may also be aligned in the same direction with the arches ofstent section 106. These larger arches may be the first components ofthe stent to be deployed during the distal to proximal release of thevalved-stent from its first, unexpanded configuration to its second,expanded configuration in a cardiac valve replacement, for example, anaortic valve replacement. In such an aortic valve replacement, thedeployed section 108 arches may be used to engage the ascending aortathereby orientating the delivery system/valved-sent longitudinallywithin the aorta/aortic annulus, thus preventing any tilting of theimplanted valved-stent. In some embodiments, a radiopaque marker 112 maybe positioned on or close to an end (e.g., the distal end) of at leastone of the arches. A function of such a radiopaque marker is describedbelow in connection with FIGS. 15A-D.

In some embodiments, the larger arches of stent section 108 may be atleast partially of cylindrical shape when fully expanded and may deformto a conical shape when only partially deployed. This may result inlower local stresses in the aortic wall, thus reducing the risks ofinflammation/perforation.

In some embodiments, the overall stent length may be sufficiently smallso as to avoid conflict with, for example, the mitral valve when thestent is being used for aortic valve replacement. Of course, it will beunderstood that these dimensions will vary depending on, for example,the type of valve used and the dimensions given above are included asexamples only and other sizes/ranges are available which conform to thepresent disclosure.

In still other embodiments of the present disclosure, a replacementvalve for use within a human body is provided that includes a valvecomponent, a stent component for housing the valve component, and atleast two skirts (e.g., polyester (PET) skirts). An inner skirt may beprovided that covers at least a portion (e.g., all) of an outer surfaceof the valve component, where the inner skirt may be sutured to at leastthe inflow tract of the valve component and to an inner surface of thestent. An outer skirt may also be provided that is sutured onto an outersurface of the stent.

FIG. 1B shows one embodiment of a self expanding stent 100. FIG. 1Bshows the placement of a double polyester (PET) fabric skirt (dashedline representing inner PET fabric skirt 122 and outer PET fabric skirt126) relative to a stent component, as well as placement of avalve-component within the stent (e.g., aortic biologic valveprosthesis, dashed line 124), according to some embodiments of thepresent disclosure. An inner skirt may cover at least a portion—forexample, either a minor portion (e.g., less than about 20% coverage), asubstantial portion (e.g., about 50-90% coverage), or all (e.g., 90%+)of the stent) of the outer surface of the replacement valve. The skirtmay be sutured to at least the inflow tract of the valve and to theinner surface of the stent, and may serve as a sealing member betweenthe stent and the valve. In some embodiments, the topology of the innersurface of this fabric may be configured to improve blood flow. An outerskirt may also be sutured onto the outer surface of the stent (dashedline 126) and may serve as a sealing member between the stent and, forexample, a native valve leaflets/cardiac valve (e.g., aortic)annulus/inflow and/or outflow tract. In some embodiments, the topologyof the outer surface of this fabric may be configured to improveendothelialisation, for example. The skirt may be made using any knowmaterial used for such purposes. Preferably, the skirt is comprised of apolyester material, such as a single ply polyester material. Thepreferred polyester is polyethylene terephthalate (PET).

A double PET fabric skirt may be provided in which the free edge of thestent is covered to avoid injuries of the left ventricle wall and mitralvalve (see e.g., FIG. 12).

FIG. 2A shows an unrolled, flat depiction of another embodiment of astent component according to some embodiments of the present disclosure.This stent component may be the same or similar to the stent componentof FIG. 1, and include the same numbering scheme as set out for FIG. 1,except that the corresponding reference numeral starts with a “2”instead of a “1”. The stent component illustrated in FIG. 2A includessome additional features, mainly one or more additional reinforcements214 for stent section 206, as well as one or more attachment elements216 in stent section 202. This numbering scheme is generally usedthroughout the specification.

Additional reinforcements 214 may comprise arches, which may be invertedas compared to the commissural arches currently provided in stentsection 206. Attachment elements 216 may be used to removable attach thestent component to a delivery device (e.g., a catheter based system). Insome embodiments, elements 216 may serve to hold the stent-valve ontothe delivery system until full release of the stent duringdelivery/implantation, thus allowing for, in some embodiments, therecapture of the stent upon partial release. See FIG. 16-18. Theattachment elements 216 may also prevent the stent from “jumping out” ofthe delivery system just prior to its full release—such jumping out mayresult in inaccurate positioning of the replacement valve.

In some embodiments, a radiopaque marker 212 may be positioned on orclose to an end (e.g., the distal end) of at least one of the arches. Afunction of such a radiopaque marker is described below in connectionwith FIGS. 15A-D.

FIG. 2B show another design of the devices of the current embodiments.The stent component illustrated in FIG. 2A-B includes some additionalfeatures, mainly one or more additional reinforcements 214 for stentsection 206, as well as one or more attachment elements 216 in stentsection 202. Such attachment elements may be formed generally in theshape of a bent, or curved angled member (e.g., an “

” or “

” like shape). In some embodiments, such attachment elements may be ahook (e.g., a “J” like shape).

Some embodiments of the present disclosure include, for example stentsand valved-stents: for anchoring towards the ascending aorta; foranchoring towards the left ventricle; for valve fixation; and/or forvalved-stent stabilization, as well as other possible applications.

FIGS. 3A-B and 4 show examples of stent designs based on suchembodiments.

FIGS. 3A and 3B show a stent design with longitudinal elements forcommissural valve fixation. FIG. 3B shows an unrolled, flat depiction ofthe above stent design. These figures show the stabilization arch 308(conically shaped section), reinforcement crown 306 (cylindricalsection), longitudinal valve fixation elements 320 (cylindricalsection), forward anchoring crown 304 (e.g., towards LV or otherwisepreventing movement of device in a direction opposite of blood flow)(conically shaped section), and reverse anchoring crown 302 (e.g.,towards ascending aorta or otherwise preventing movement of device inthe direction of blood flow) (conically shaped section).

An unrolled, flat depiction of an alternative design for a stent withoutreinforcement crowns is in FIG. 4. FIG. 4 shows the stabilization arch408 (conically shaped section), longitudinal valve fixation elements 420(cylindrical section), forward anchoring crown 404 (e.g., towards LV orotherwise preventing movement of device in the direction of blood flow)(conically shaped section), and reverse anchoring crown 402 (e.g.,towards ascending aorta or otherwise preventing movement of device in adirection opposite of blood flow) (conically shaped section). Thereverse anchoring crown 402 may be comprised of two rows (plurality) ofmeanders for improved stability. In preferred embodiments, the fixationelements 420 together help to form the cylindrical shape of the optionalthird section of the stent. That is, the fixation elements 420 arepreferably curved around the longitudinal axis of the stent and, in someembodiments, may form the circumference of the third section of thestent.

In some embodiments, a stent is presented which includes a section forcommissural valve fixation which is composed of a plurality (e.g., two,three, four, five, six, eight, etc.) longitudinal elements connected onone side to a conically shaped section (for example) used for anchoringtowards the left ventricle and on the other side to the conically shapedsection (for example) used for stabilization.

According to some embodiments, the stent is designed to better match thesize and shape of a biological valve with narrow commissural posts and,in some embodiments, allow a more robust suturing of the valvecommissural posts to the stent. Narrow commissural posts according tosome embodiments improve the perfusion of the coronary arteries via thesinus of vasalva. To reduce the deflection of the three longitudinalelements under diastolic pressure, an additional reinforcement crown maybe added as well in some embodiments.

According to some embodiments, the stent design allowing for thefixation of the valve commissural posts, according to some embodiments,provides a further advantage, as the size and shape of such stentspreferably does not change substantially, and even more preferably, doesnot change during a required crimping process for loading the stent(with valve, “valved-stent”) onto a delivery catheter. Accordingly, thismay reduce (and preferably does reduce) the risks of suture damage andfacilitating crimping and subsequently releasing of the valved-stent(for example).

Although a number of embodiments are herein described, othermodifications are possible, and thus, the noted embodiments are forillustrative purposes only.

FIG. 5 is provided to illustrate the dimensions of the first and secondsections of the stent component. With respect to the first section, D3represents the diameter of the most proximal edge of the stent componentin the expanded configuration. D2 represents the diameter of the stentcomponent at the juncture between the first conical section 502 andsecond conical section 504 of the stent component. H2 represents theaxial distance between the planes of the diameters D2 and D3 in theexpanded configuration, or the length of the first conical section inthe expanded configuration. D1 represents the diameter of the mostdistal edge of the second conical section of the stent component in theexpanded configuration. H1 represents the axial distance between theplanes of the diameters D1 and D2 in the expanded configuration, or thelength of the second conical section in the expanded configuration.

Preferably, the length of the first conical section H2 is between about3 to about 15 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm,about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12mm, about 13 mm, about 14 mm, and about 15 mm). The length of the firstconical section H2 may been adjusted depending on the intendedapplication of the stent of stent-valve. For example, the length of thefirst conical section 1-12 may range from about 3 to about 5 mm, about 3to about 7 mm, about 3 to about 12 mm, about 3 to about 15 mm, about 3to about 20 mm, about 5 to about 10 mm, about 5 to about 12 mm, about 5to about 15 mm, about 7 to about 10 mm, about 7 to about 12 mm, about 7to about 15 mm, about 10 to about 13 mm, about 10 to about 15 mm, orabout 7 to about 20 mm. For example, the length of this section may beon the smaller end of the scale to avoid potential conflict with acardiac valve, such as the mitral valve.

The diameter of the first conical section at D3 is preferably betweenabout 22 mm to about 40 mm (e.g., about 22 mm, about 23 mm, about 24 mm,about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about30 mm, about 31 mm, about 32 mm, about 33 mm, about 34 mm, about 35 mm,about 36 mm, about 37 mm, about 38 mm, about 39 mm, and about 40 mm).This diameter of the first conical section D3 may been adjusteddepending on the intended application of the stent of stent-valve. Thus,the diameter of the first conical section in the expanded configurationD3 may be from between about 15 mm to about 50 mm, from between about 15mm to about 40 mm, from between about 20 mm to about 40 mm, from betweenabout 24 mm to about 40 mm, from between about 26 mm to about 40 mm,from between about 28 mm to about 40 mm, from between about 30 mm toabout 40 mm, from between about 32 mm to about 40 mm, from between about34 mm to about 40 mm, from between about 36 mm to about 40 mm, frombetween about 38 mm to about 40 mm, from between about 22 mm to about 38mm, from between about 22 mm to about 36 mm, from between about 22 mm toabout 34 mm, from between about 22 mm to about 32 mm, from between about22 mm to about 30 mm, from between about 22 mm to about 28 mm, frombetween about 24 mm to about 34 mm, from between about 25 mm to about 35mm, or from between about 25 mm to about 30 mm.

The diameter of the stent component D2 at the juncture of the first andsecond conical sections D2 is preferably between about 20 mm to about 30mm (e.g., about 20 mm, about 21 mm, about 22 mm, about 23 mm, about 24mm, about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, andabout 30 mm). This diameter of the stent component D2 may been adjusteddepending on the intended application of the stent of stent-valve. Forexample, this diameter of the stent component D2 may be sized accordingto the shape of the annulus of the cardiac valve. Thus, the diameter ofthe stent component D2 may be from between about 15 mm to about 40 mm,from between about 15 mm to about 30 mm, from between about 18 mm toabout 35 mm, from between about 22 mm to about 30 mm, from between about24 mm to about 30 mm, from between about 26 mm to about 30 mm, frombetween about 28 mm to about 30 mm, from between about 22 mm to about 28mm, from between about 22 mm to about 26 mm, from between about 20 mm toabout 24 mm, from between about 20 mm to about 26 mm, from between about20 mm to about 28 mm, and from between about 22 mm to about 32 mm.

The diameter of the second conical section at D1 is preferably betweenabout 22 mm to about 40 mm (e.g., about 22 mm, about 23 mm, about 24 mm,about 25 mm, about 26 mm, about 27 mm, about 28 mm, about 29 mm, about30 mm, about 31 mm, about 32 mm, about 33 mm, 34 mm, 35 mm, 36 mm, 37mm, about 38 mm, about 39 mm, and about 40 mm). This diameter of thesecond conical section D1 may been adjusted depending on the intendedapplication of the stent of stent-valve. Thus, the diameter of the firstconical section in the expanded configuration D1 may be from betweenabout 15 mm to about 50 mm, from between about 15 mm to about 40 mm,from between about 20 mm to about 40 mm, from between about 24 mm toabout 40 mm, from between about 26 mm to about 40 mm, from between about28 mm to about 40 mm, from between about 30 mm to about 40 mm, frombetween about 32 mm to about 40 mm, from between about 34 mm to about 40mm, from between about 36 mm to about 40 mm, from between about 38 mm toabout 40 mm, from between about 22 mm to about 38 mm, from between about22 mm to about 36 mm, from between about 22 mm to about 34 mm, frombetween about 22 mm to about 32 mm, from between about 22 mm to about 30mm, from between about 22 mm to about 28 mm, from between about 24 mm toabout 34 mm, from between about 25 mm to about 35 mm, or from betweenabout 25 mm to about 30 mm.

Preferably, the length of the second conical section H1 is between about3 to about 10 mm (e.g., about 3 mm, about 4 mm, about 5 mm, about 6 mm,about 7 mm, about 8 mm, about 9 mm, and about 10 mm). The length of thefirst conical section H1 may been adjusted depending on the intendedapplication of the stent of stent-valve. For example, the length of thefirst conical section H2 may range from about 3 to about 5 mm, about 3to about 15 mm, about 3 to about 20 mm, about 5 to about 10 mm, about 7to about 10 mm, about 7 to about 12 mm, about 7 to about 15 mm, about 10to about 13 mm, about 5 to about 15 mm, about 7 to about 20 mm. Forexample, the length of this section may be on the smaller end of thescale to avoid potential conflict with a cardiac valve, such as themitral valve.

FIG. 6 is provided to illustrate the dimensions of the first and secondsections of the stent component, and particularly the angles of theanchoring crowns that help to define these conical sections. The alangle defines the angle of the anchoring crown of the second conicalsection of the stent component in the expanded configuration. The α2angle defines the angle of the anchoring crown of the first conicalsection of the stent component in the expanded configuration. The α3angle defines the angle of bending of the tip, which is done so as toprevent injuries of sinus (see also, FIG. 10).

The α1 angle is preferably between from about 10 degree to about 80degree (e.g., about 10 degree, about 15 degree, about 20 degree, about25 degree, about 30 degree, about 35 degree, about 40 degree, about 45degree, about 50 degree, about 55 degree, about 60 degree, about 65degree, about 70 degree, about 75 degree, and about 80 degree), morepreferably between from about 20 degree to about 70 degree, mostpreferable between from about 30 degree to about 60 degree. According tosome embodiments, the α1 angle is between from about 20 degree to about80 degree, between from about 20 degree to about 60 degree, between fromabout 20 degree to about 50 degree, between from about 20 degree toabout 45 degree, between from about 40 degree to about 60 degree,between from about 45 degree to about 60 degree, between from about 30degree to about 50 degree, between from about 30 degree to about 45degree, between from about 30 degree to about 40 degree, or between fromabout 25 degree to about 45 degree.

The α2 angle is preferably between from about 5 degree to about 50degree (e.g., about 5 degree, about 10 degree, about 15 degree, about 20degree, about 25 degree, about 30 degree, about 35 degree, about 40degree, about 45 degree, and about 50 degree), more preferably betweenfrom about 10 degree to about 40 degree, most preferable between fromabout 10 degree to about 30 degree. According to some embodiments, theα2 angle is between from about 5 degree to about 45 degree, between fromabout 5 degree to about 40 degree, between from about 5 degree to about30 degree, between from about 5 degree to about 25 degree, between fromabout 5 degree to about 20 degree, between from about 5 degree to about15 degree, between from about 10 degree to about 20 degree, between fromabout 10 degree to about 25 degree, between from about 10 degree toabout 30 degree, between from about 10 degree to about 40 degree,between from about 10 degree to about 45 degree, between from about 15degree to about 40 degree, between from about 15 degree to about 30degree, between from about 15 degree to about 25 degree, between fromabout 20 degree to about 45 degree, between from about 20 degree toabout 40 degree, or between from about 20 degree to about 30 degree

The α3 angle is preferably between from about 0 degree to about 180degree (e.g., about 5 degree, about 10 degree, about 15 degree, about 20degree, about 25 degree, about 30 degree, about 35 degree, about 40degree, about 45 degree, about 50 degree, about 55 degree, about 60degree, about 65 degree, about 70 degree, about 75 degree, about 80degree, about 85 degree, about 90 degree, about 95 degree, about 100degree, about 105 degree, about 110 degree, about 115 degree, about 120degree, about 125 degree, about 130 degree, about 135 degree, about 140degree, about 145 degree, about 150 degree, about 155 degree, about 160degree, about 165 degree, about 170 degree, about 175 degree, and about180 degree). According to some embodiments, the α3 angle is between fromabout 45 degree to about 90 degree, between from about 45 degree toabout 180 degree, between from about 60 degree to about 90 degree,between from about 45 degree to about 120 degree, between from about 60degree to about 120 degree, between from about 90 degree to about 120degree, between from about 90 degree to about 180 degree, or betweenfrom about 120 degree to about 180 degree.

FIG. 7 shows the size and shape of stabilization arches for the stentcomponent in the expanded configuration according to some embodiments ofthe disclosure. The α4 and α5 angles represent the offset angle from alongitudinal axis of the stabilization arches of the forth section ofthe stent in the expanded configuration. If the stabilization arches aredirected away from the center of the stent, the α4 angle is used. If thestabilization arches are directed toward from the center of the stent,the α5 angle is used.

The α4 angle is preferably between from about 0 degree to about 60degree (e.g., about 5 degree, about 10 degree, about 15 degree, about 20degree, about 25 degree, about 30 degree, about 35 degree, about 40degree, about 45 degree, about 50 degree, about 55 degree, and about 60degree). According to some embodiments, the α4 angle is between fromabout 20 degree to about 60 degree, between from about 30 degree toabout 60 degree, between from about 40 degree to about 60 degree,between from about 45 degree to about 60 degree, between from about 30degree to about 50 degree, between from about 30 degree to about 45degree, between from about 20 degree to about 40 degree, or between fromabout 15 degree to about 45 degree.

The α5 angle is preferably between from about 0 degree to about 20degree (e.g., about 5 degree, about 10 degree, about 15 degree, andabout 20 degree). According to some embodiments, the α5 angle is betweenfrom about 5 degree to about 20 degree, between from about 10 degree toabout 20 degree, between from about 15 degree to about 20 degree,between from about 0 degree to about 15 degree, between from about 0degree to about 10 degree, between from about 5 degree to about 15degree, between from about 10 degree to about 15 degree, or between fromabout 10 degree to about 20 degree.

FIG. 7 also shows the length of the first section of the stent componentH2, the length of the combined second section and optional third sectionof the stent component H3, and the length of the forth section of thestent component H1. H2 is as described above.

Preferably, the length of the combined second section and optional thirdsection of the stent component H3 is between about 3 to about 50 mm(e.g. about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm,about 14 mm, about 15 mm, about 20 mm, about 22 mm, about 24 mm, about25 mm, about 26 mm, about 28 mm, about 30 mm, about 32 mm, about 34 mm,about 36 mm, about 38 mm, about 40 mm, about 42 mm, about 44 mm, about45 mm, about 46 mm, about 48 mm, and about 50 mm). The length of thefirst conical section H3 may been adjusted depending on the intendedapplication of the stent of stent-valve. For example, the length of thefirst conical section H3 may range from about 3 to about 40 mm, about 3to about 30 mm, about 3 to about 20 mm, about 3 to about 10 mm, about 10to about 50 mm, about 10 to about 40 mm, about 10 to about 30 mm, about10 to about 20 mm, about 15 to about 50 mm, about 15 to about 40 mm,about 15 to about 30 mm, about 20 to about 50 mm, about 20 to about 40mm, about 20 to about 30 mm, about 15 to about 50 mm, about 25 to about50 mm, about 30 to about 50 mm, about 40 to about 50 mm, about 15 toabout 40 mm, about 25 to about 40 mm, or about 30 to about 40 mm.According to some embodiments of the stent component, the third sectionof the stent component is not used. Thus, H3 would be the same as H1,described above.

Preferably, the length of the forth section and of the stent componentH4 is between about 5 to about 50 mm (e.g., about 5 mm, about 6 mm,about 7 mm, about 8 mm, about 9 min, about 10 mm, about 11 mm, about 12mm, about 13 mm, about 14 mm, about 15 mm, about 20 mm, about 22 mm,about 24 mm, about 25 mm, about 26 mm, about 28 min, about 30 mm, about32 mm, about 34 mm, about 36 mm, about 38 mm, about 40 mm, about 42 mm,about 44 mm, about 45 min, about 46 mm, about 48 mm, and about 50 mm).The length of the first conical section H4 may been adjusted dependingon the intended application of the stent of stent-valve. For example,the length of the first conical section H4 may range from about 5 toabout 40 mm, about 5 to about 30 mm, about 5 to about 20 mm, about 5 toabout 10 mm, about 10 to about 50 mm, about 10 to about 40 mm, about 10to about 30 mm, about 10 to about 20 mm, about 15 to about 50 mm, about15 to about 40 mm, about 15 to about 30 mm, about 20 to about 50 mm,about 20 to about 40 mm, about 20 to about 30 mm, about 15 to about 50mm, about 25 to about 50 mm, about 30 to about 50 mm, about 40 to about50 mm, about 15 to about 40 mm, about 25 to about 40 mm, or about 30 toabout 40 mm.

Using the dimensions described above (i.e., D1, D2, D3, H1, H2, H3, H4,α1, α2, α3, and α4), the stent components of the stent-valves accordingto some embodiments of the present disclosure may be classified intodifferent categories of sizes, such as small, medium, and large. Thus,according to some embodiments, the stent components (or stent valves)may be sized as small, medium, and large according the following table.

Small Medium Large D1 [mm] 26-31 27-32 28-33 D2 [mm] 20-25 21-26 22-27D3 [mm] 26-32 27-33 28-34 H1 [mm] 4-8 4-8 4-8 H2 [mm]  7-11  8-12  9-13H3 [mm] 11-15 13-17 15-19 H4 [mm] 14-22 15-23 16-24 α1 45°-65° 45°-65°45°-65° α2 15°-25° 15°-25° 15°-25° α3 45°-65° 45°-65° 45°-65° α4  5°-15° 5°-15°  5°-15°

FIG. 8 shows a mating coupling between the attachment elements 316 ofthe stent and a stent-holder of a delivery device, according to someembodiments of the present disclosure. As shown, at least one, andpreferably a plurality or all of the attachment elements may include acrochet-like configuration that engages, for example, a groove or otheropening within the stent holder. Such attachment elements may be formedgenerally in the shape of a bent, or curved angled member (e.g., an “L”or “)” like shape).

In some embodiments, such attachment elements may be a hook (e.g., a “J”like shape). In the embodiment illustrated in FIG. 8, the attachmentelement may be provided in an angled shape, for example, that extendsfrom the body of the stent inwardly toward a central, longitudinal axisof the stent. The opening in the stent holder (e.g., groove) may allowfor a safe release of the stent upon rotation of the delivery system(e.g., a portion, all or members thereof—e.g., rotation of the stentholder). For example, when rotating the delivery system/stent holder,the end of the attachment element slides onto the surface “S” and isthereby forced, according to some embodiments, to disengage the stentholder when reaching the edge “E”.

In some embodiments, multiple fixation elements (e.g., 2 or more, 3 ormore, 4 or more, 5 or more, 6 or more, 7 or more, 8 or more, 9 or more,10 or more, 11 or more, 12 or more, 13 or more, 14 or more, 15 or more,16 or more, 17 or more, 18 or more, 19 or more, 20 or more, etc. or 2 to5, 2 to 10, 2 to 20, 2 to 30, 2 to 40, etc.) may be provided for holdingthe stent onto a catheter whereas a matching/complimentary element(e.g., stent holder with pins) may be attached to the catheter. Thedesign of the multiple fixation elements (e.g., forming “holes”) mayallow for the fixation of the stent onto the catheter only when thestent is crimped (see e.g., FIG. 9). The fixation may releaseautomatically when the stent starts to expand. That is, the shape of thestent in the unexpanded state is designed to have holes or free areasthat can be used to couple the stent with a stent holder. When the stentis expanded, the expanded configuration is absent suchs holes or freespaces and thus the stent automatically becomes uncoupled or releasesfrom the stent holder upon expansion.

It has been observed in vivo that the design of the stent componentallows for self-positioning of the replacement valve under diastolicpressure. Once delivered slightly above the aortic annulus, thestent-valve migrates toward the left ventricle due to the forces causedby the diastolic pressure until it reaches a stable position given bythe shape/radial force of the anchoring crown (conically shaped section2) and the compliance of the aortic annulus (FIG. 13).

For example, with respect to some embodiments of the disclosure, andwith reference to FIG. 1A, the stent-valve may be released such that atleast a portion of section 102 of the stent component is released at thenative valve annulus (e.g., release position). In some preferredembodiments, the release of the stent valve in the release positionpreferably comprises a full release of the stent valve (i.e., thestent-valve is fully released from the delivery system). Accordingly,subsequent beating of the heart after release results in the stent-valvesliding into a final position, which preferably is the groove formedbetween stent component sections 102 and 104. The distance between therelease position and the final position, which may be in reference toeither locations at the implantation site (e.g., within the lumen/heart)and/or locations on the stent component, may comprise a predeterminedrange, which may include: between about 3 mm and about 20 mm, betweenabout 7 mm to about 11 mm, between about 8 mm to about 12 mm, andbetween about 9 mm to about 13 mm.

While preferred embodiments are directed toward releasing thestent-valve as described above (e.g., paragraph [00105]) at a releaselocation on stent component section 102, in still other embodiments, andwith reference to FIG. 1A, the stent-valve may be released (whichaccording to some embodiments, is a full release from the stent-valvedelivery system) such that at least a portion of section 104 of thestent component is released at the native valve annulus (e.g., releaseposition), and subsequent beating of the heart after release results inthe stent-valve sliding into a final position which preferably is thegroove portion (as indicated above) between sections 104 and 102.Accordingly, a range of distances between release locations and finalpositions, which may be in reference to either locations at theimplantation site (e.g., within the lumen/heart) and/or locations on thestent component, may be between about 4 mm and 8 mm.

In some embodiments, a valved-sent delivery system, and method fordelivering the valved-stent to an implantation site are provided inwhich the valved-sent is expanded at the implantation site in a stepwisemanner (for example) from its distal end towards its proximal end. Forexample, a release procedure for causing expansion of a valved-stent mayinvolve pulling back a sheath element on a catheter delivery device. Thesheath element, in such an embodiment, constrains the valved-sent towarda section of the heart (for example, the left ventricle of the heart).According to such a procedure, there may be no interaction of thedelivery system with the anatomy of the ascending aorta/aortic arch. Forexample, the sheath constraining the valved-stent, and the tip of thedelivery system may not be required to enter the aortic arch during therelease procedure, which is beneficial since such entry potentially cancause a bending moment acting onto the valved- stent and result ininaccurate positioning of the valved-stent (e.g., tilting).

Cardiac Stent Valve Delivery System

Some embodiments of the present disclosure provide a cardiac stent-valvedelivery system that includes an inner assembly and an outer assembly.The inner assembly may include a guide wire lumen (e.g., polymerictubing) and a stent bolder for removable attachment to a stent-valve.The outer assembly may include a sheath. The inner member and the outermember may be co-axially positioned and slidable relative to one anotherin order to transition from a closed position to an open position, suchthat in the closed position the sheath encompasses the stent-valve stillattached to the stent holder and thus constrains expansion of thestent-valve. In the open position, the outer sheath may not constrainexpansion of the stent-valve and thus the stent-valve may detach fromthe stent holder and expand to a fully expanded configuration.

In some embodiments, the inner assembly of the delivery device mayinclude a fluoroscopic marker fixed to the guide wire lumen distal ofthe stent holder.

In some embodiments, the diameter of the outer assembly of the deliverydevice varies over its longitudinal axis.

In still other embodiments, the delivery system comprises a rigid (e.g.,stainless steel) shaft in communication with a proximal end of the guidewire lumen.

In some embodiments, the delivery system comprises a luer connector incommunication with the rigid shaft.

FIG. 14A shows a delivery system 550 for distal-to-proximal expansion ofa stent-valve (i.e., section 108 to section 102—see FIG. 1), accordingto some embodiments of the present disclosure. In some embodiments ofthe delivery system, the system 550 may include an inner member 552 andan outer member 554 (e.g., sheath) which are co-axially positioned andslidable one against the other. The inner member 552 may comprise tubing568 (e.g., polymeric tubing) which serves as a guide wire lumen and onwhich at least one of (and preferably several or all) a tip 556, afluoroscopic marker 558, and a stent-holder 560 are affixed (e.g.,bonded). The polymeric tubing may be reinforced proximally with a rigid(e.g., stainless steel) shaft. A luer connector 562 affixed to astainless steel shaft 564 to allow flushing of the guide wire lumen withsaline (for example). The outer member 554 may comprise a distallyarranged sheath which may be used to constrain the stent in aclosed/contracted (e.g., substantially non-expanded) configuration.Proximally, the sheath may be fixed to a hemostasis valve 566 to allowthe flushing of the annular space between the inner and outer memberswith saline (for example). In some embodiments, the diameter of theouter member may vary over its longitudinal direction (e.g., smallerdiameter proximally to decrease the bending stiffness of the deliverysystem). In some embodiments, the deployment of the stent-valve mayoccur by holding the inner member at the level of the stainless steelshaft with one hand and the outer member at the level of the hemostasisvalve with the other hand. Then, upon positioning of the replacementvalve (e.g., under fluoroscopic control), the outer member is pulledback with the inner member being kept at its original position, untilthe stent is fully deployed.

FIG. 14B shows the size and shape of delivery system according to someembodiments. Ds refers to the stent sleeve diameters, which are theinner and outer sleeve diameters. The inner diameter of the stent sleeveis preferably from between about 4 to about 14 mm (e.g., about 4 mm, 5mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm). Theouter diameter of the stent sleeve is preferably from between about 5 toabout 15 mm (e.g., about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12mm, 13 mm, 14 mm, or 15 mm).

Ls refers to the stent sleeve length. The stent sleeve length ispreferably from between about 20 mm to about 120 mm (e.g., about 20 mm,25 mm, 30 mm, 35 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm,110 mm, or 120 mm). According to some embodiments, the stent sleevelength is between from about 20 mm to about 100 mm, about 20 mm to about80 mm, about 20 mm to about 60 mm, about 20 mm to about 40 mm, about 40mm to about 120 mm, about 60 mm to about 120 mm, about 80 mm to about120 mm, about 100 mm to about 120 min, about 40 mm to about 100 mm, orabout 60 mm to about 100 mm.

Lu refers to the usable length. The usable length is preferably frombetween about 150 mm to about 500 mm (e.g., about 150 mm, 175 mm, 200mm, 225 mm, 250 mm, 300 mm, 350 mm, 400 mm, 450 mm, or 500 mm).According to some embodiments, the usable length is between from about150 mm to about 450 mm, about 150 mm to about 400 mm, about 150 mm toabout 350 mm, about 150 mm to about 300 mm, about 150 mm to about 250mm, about 200 mm to about 500 mm, about 300 mm to about 500 mm, about350 mm to about 500 mm, about 400 mm to about 500 mm, about 200 mm toabout 400 mm, or about 300 mm to about 400 min.

Lt refers to the total length. The total length is preferably frombetween about 200 mm to about 1000 mm (e.g., about 200 mm, 225 mm, 250mm, 300 mm, 350 mm, 400 mm, 450 mm, 500 mm, 550 mm, 600 mm, 650 mm, 700mm, 750 mm, 800 mm, 850 mm, 900 mm, 950 mm, or 1000 mm). According tosome embodiments, the total length is between from about 200 mm to about900 mm, about 200 mm to about 800 mm, about 200 mm to about 700 mm,about 200 mm to about 600 mm, about 200 mm to about 500 mm, about 200 mmto about 400 mm, about 200 mm to about 300 mm, about 300 mm to about1000 mm, about 400 mm to about 1000 mm, about 500 mm to about 1000 mm,about 600 mm to about 1000 mm, about 700 mm to about 1000 mm, about 800mm to about 1000 mm, about 900 mm to about 1000 mm, or about 300 mm toabout 800 mm.

FIGS. 15A-D illustrate an exemplary embodiment of a method of implantinga stent-valve within a human heart according to some embodiments of thepresent disclosure (e.g., an aortic valve replacement). Accordingly,FIG. 15A shows the initial, partial release of the stent 1500, in whichthe radiopaque 1512 marker positioned on one of the arches of stentsection 1508 (see FIG. 1), for example, is released distally from theouter sheath . By tracking the radiopaque marker 1512, the deliverysystem 1550 may then be rotated as necessary in order to orient thestent 1500 appropriately with respect to, for example, the coronaryarteries (e.g., orienting the stent-valve such that the commissures donot face the coronary arteries). More specifically, prior to fullrelease of the stent 1500, the delivery system 1550 may be rotated inorder to cause the radiopaque marker 1512 to be placed between theosteum of the left and right coronary arteries.

FIG. 1513 shows a further, but still partial release of the stent 1500,in which the larger, orientation arches 1509 of stent section 1508 arereleased from the outer sheath 1554 and placed into contact with theaorta (for example).

FIG. 15C illustrates an example of yet a further, still partial releasebut almost fully released, illustration of the stent release, in whichthe first conical crown of stent section 1504 is released from the outersheath 1554 for engagement with the native valve leaflets 1580.

FIG. 15D illustrates an example of a full release of the stent, in whichthe second conical crown of stent section 1502 (i.e., the proximalsection of the stent; see FIG. 1) is released from the outer sheath 1554for engagement with the annulus/inflow tract.

Medical Uses

According to some embodiments, cardiac stent-valves are provided ascardiac replacement valves. There are four valves in the heart thatserve to direct the flow of blood through the two sides of the heart ina forward direction. On the left (systemic) side of the heart are: 1)the mitral valve, located between the left atrium and the leftventricle, and 2) the aortic valve, located between the left ventricleand the aorta. These two valves direct oxygenated blood coming from thelungs through the left side of the heart into the aorta for distributionto the body. On the right (pulmonary) side of the heart are: 1) thetricuspid valve, located between the right atrium and the rightventricle, and 2) the pulmonary valve, located between the rightventricle and the pulmonary artery. These two valves directde-oxygenated blood coming from the body through the right side of theheart into the pulmonary artery for distribution to the lungs, where itagain becomes re-oxygenated to begin the circuit anew.

Problems that can develop with heart valves consist of stenosis, inwhich a valve does not open properly, and/or insufficiency, also calledregurgitation, in which a valve does not close properly. In addition tostenosis and insufficiency of heart valves, heart valves may need to besurgically repaired or replaced due to certain types of bacterial orfungal infections in which the valve may continue to function normally,but nevertheless harbors an overgrowth of bacteria on the leaflets ofthe valve that may embolize and lodge downstream in a vital artery. Insuch cases, surgical replacement of either the mitral or aortic valve(left-sided heart valves) may be necessary. Likewise, bacterial orfungal growth on the tricuspid valve may embolize to the lungs resultingin a lung abscess. In such cases replacement of the tricuspid valve eventhough no tricuspid valve stenosis or insufficiency is present.

According to some embodiments, there is provided a method for replacinga worn or diseased valve comprising transapically implanting areplacement valve, wherein the replacement valve is a stent-valve of thepresent disclosure. Accordingly, the replacement valve comprises a valvecomponent and a stent component, wherein the valve component is connectto the stent component.

The stent component preferably comprises a longitudinal axis andpreferably has four sections. The first section, as above, includes asubstantially conical shape having a narrow end, a broad end and apredetermined first height. The second section, as above, includes asubstantially conical shape having a narrow end, a broad end and apredetermined second height. The center of each of the first section andthe second section are preferably arranged to align substantially withthe longitudinal axis. The narrow ends of the first section and secondsection are preferably arranged to meet forming an annular groove toreceive the annulus of worn or diseased cardiac valve at an implantationsite of the heart. The first height of the first section is preferablygreater than the second height of the second section. Upon implantation,the replacement valve is positioned so that the annular groove receivesthe annulus of the worn or diseased cardiac valve.

As the stent-valves of the present disclosure are designed to beself-positioning under diastolic pressure (i.e., permissible in vivomigration), the placement of the stent-valve may be upstream of theannulus, whereupon when the stent-valve will be locked into positiononce the annular groove of the stent component receives the annulus.Thus, according to some embodiments, methods are provided for implantinga replacement valve into a heart of a mammal comprising delivering areplacement valve to an implantation site of the heart of the mammal.The implantation site preferably comprises a release location and afinal location; and the release location is spaced apart from the finallocation (and according to some embodiments, the spacing comprises apredetermined distance), and in some embodiments, in a blood upflowdirection. Releasing the replacement valve at the release location, thereplacement valve is able to slide into the final location, generallyupon at least one beat of the heart subsequent to the replacement valvebeing released at the release location.

According to some embodiments, the methods provides that when thereplacement valve sliding into the final location, the replacement valveis substantially positioned to the final location.

In some embodiments of the present disclosure, a method is provided forreplacing an aortic valve within a human body. A stent-valve may becovered with a sheath in order to maintain the stent-valve in acollapsed configuration. The stent-valve may then may be inserted in thecollapsed configuration into the human body without contacting theascending aorta or aortic arch. The stent-valve may be partiallyexpanded by sliding the sheath towards the left ventricle of the heart.This sliding of the sheath towards the left ventricle may causeexpansion of a distal end of the stent-valve while the proximal end ofthe stent-valve remains constrained by the sheath. The sheath may befurther slid towards the left ventricle of the heart in order to causefull expansion of the stent-valve. In some embodiments, the stent-valvemay be recaptured prior to its full expansion by sliding the sheath inthe opposite direction.

In some embodiments, a method for cardiac valve replacement is providedthat includes releasing a distal end of a stent-valve from a sheath,where the distal end includes a radiopaque marker positioned thereon.The stent-valve is rotated, if necessary, to orient the stent-valveappropriately with respect to the coronary arteries (e.g., to preventthe commissures from facing the coronary arteries). Arches of thestent-valve are released from the sheath, in order to cause the archesto contact the aorta. A first conical crown of the stent-valve isreleased from the sheath, in order to cause the first conical crown tocontact the native valve leaflets. A second crown of the stent-valve isreleased from the sheath, in order to cause the second crown to contactan annulus/inflow tract. The second crown may be the proximal section ofthe stent-valve such that releasing the second crown causes thestent-valve to be fully released from the sheath.

According to some embodiments, a replacement valve for use within ahuman body is provided, where the replacement valve includes a valvecomponent and a stent component. The stent component also may be usedwithout a connected valve as a stent. The stent devices of the presentdisclosure may use used to mechanically widen a narrowed or totallyobstructed blood vessel; typically as a result of atherosclerosis.Accordingly, the stent devices of the present disclosure may use used isangioplasty procedures. These include: percutaneous coronaryintervention (PCI), commonly known as coronary angioplasty, to treat thestenotic (narrowed) coronary arteries of the heart found in coronaryheart disease; peripheral angioplasty, performed to mechanically widenthe opening in blood vessels other than the coronary arteries.

Thus, it is seen that stent-valves (e.g., single-stent-valves anddouble-stent- valves) and associated methods and systems for surgery areprovided. Although particular embodiments have been disclosed herein indetail, this has been done by way of example for purposes ofillustration only, and is not intended to be limiting with respect tothe scope of the appended claims, which follow. In particular, it iscontemplated by the applicant that various substitutions, alterations,and modifications may be made without departing from the spirit andscope of invention as defined by the claims. Other aspects, advantages,and modifications are considered to be within the scope of the followingclaims. The claims presented are representative of the inventionsdisclosed herein. Other, unclaimed inventions are also contemplated. Theapplicant reserves the right to pursue such inventions in later claims.

1. (canceled)
 2. A replacement valve for use within a human bodycomprising: a stent component comprising a first end and a second endand a plurality of sections including: a first stent section defining anat least partly conical body, wherein the first stent section definesthe proximal end of the stent component; a second stent section incommunication with the first stent section and defining an at leastpartly conical body, wherein the conical body of the first stent sectionslopes outwardly in the direction of the first end, and wherein theconical body of the second stent section slopes outwardly in thedirection of the second end; a distal stent section comprising a thirdstent section in communication with the second stent section and housingat least a portion of a valve component of the replacement valve, and afourth stent section defining an at least partly conical body, whereinthe fourth stent section defines the second end and comprises valvestabilization arches for orienting the replacement valve longitudinallywithin an aorta/aortic annulus for preventing tilting of the replacementvalve when implanted; wherein each valve stabilization arch has a firstend in communication with the third section, a second end incommunication with the third section, and an apex at the second end ofthe stent component.
 3. A replacement valve for use within a human bodycomprising: a stent component comprising a first end and a second end,the stent component further comprising a plurality of sectionsincluding: a first stent section defining an at least partly conicalbody, wherein the first stent section defines the proximal end of thestent component; a second stent section in communication with the firststent section and defining an at least partly conical body, wherein theconical body of the first stent section slopes outwardly in thedirection of the first end, and wherein the conical body of the secondstent section slopes outwardly in the direction of the second end; adistal stent section comprising a third stent section in communicationwith the second stent section and housing at least a portion of a valvecomponent of the valve component of the replacement valve, and a fourthstent section defining an at least partly conical body, wherein thefourth stent section defines the second end and comprises exactly threevalve stabilization arches for orienting the replacement valvelongitudinally within an aorta/aortic annulus for preventing tilting ofthe replacement valve when implanted.
 4. The replacement valve of claim3, wherein the first stent section comprises an anchoring crown, andwherein tips of elements forming the anchoring crown of the second stentsection are bent towards the longitudinal axis of the stent.
 5. Thereplacement valve of claim 3, wherein the third section comprises atleast a partially cylindrical body.
 6. The replacement valve of claim 5,wherein the third stent section comprises valve fixation arches.
 7. Thereplacement valve of claim 6, wherein the at least partially cylindricalbody of the third stent section comprises valve fixation elements. 8.The replacement valve of claim 3, wherein the conical body of the firststent section slopes outwardly from an inner diameter D2 to an outerdiameter D3 in the direction of the first end, wherein the innerdiameter D2 is between about 20 mm to about 30 mm, and wherein the outerdiameter D3 is between about 22 mm to about 40 mm.
 9. The replacementvalve of claim 8, wherein the axial distance between the planes ofdiameters D2 and D3 in an expanded configuration is between about 3 toabout 15 mm.
 10. The replacement valve of claim 8, wherein the outwardslope of the first stent section is defined by an angle α2, and whereinα2 is between from about 5 degrees to about 50 degrees.
 11. Thereplacement valve of claim 3, wherein the conical body of the secondstent section slopes outwardly from an inner diameter D2 to an outerdiameter D1 in the direction of the second end, wherein the innerdiameter D2 is between about 20 mm to about 30 mm, and wherein the outerdiameter D1 is between about 22 mm to about 40 mm.
 12. The replacementvalve of claim 11, wherein the axial distance between the planes of thediameters D2 and D1 in an expanded configuration is about 3 mm to about10 mm.
 13. The replacement valve of claim 11, wherein the outward slopeof the second stent section is defined by an angle α1, and wherein α1 isbetween from about 10 degrees to about 80 degrees.
 14. The replacementvalve of claim 3, wherein the end of the second stent section forms atip, and wherein the tip is bent inwardly toward the longitudinal axisat an angle α3, and wherein α3 is between from about 0 degrees to about180 degrees.
 15. The replacement valve of claim 6, wherein the length ofthe combined second section and third section of the stent component isbetween about 3 mm to about 50 mm.
 16. The replacement valve of claim 6,wherein the length of the fourth section is between about 5 mm to about50 mm.
 17. The replacement valve of claim 3, wherein angle α4 representsan offset angle from a longitudinal axis of the stabilization arches ofthe stent in an expanded configuration, wherein the stabilization archesexpand outwardly at angle α4 from a longitudinal axis toward the seconddistal end of the replacement valve, and wherein α4 is between about 0degrees to about 60 degrees.
 18. The replacement valve of claim 3,wherein angle α5 represents an offset angle from a longitudinal axis ofthe stabilization arches of the stent in the expanded configuration,wherein the stabilization arches expand inwardly at angle α5 from alongitudinal axis toward the second distal end of the replacement valve,and wherein α5 is between about 0 degrees to about 20 degrees.
 19. Thereplacement valve of claim 3, further comprising attachment elements atthe first end, wherein the attachment elements are used to removablyattach the stent component to a delivery device.
 20. The replacementvalve of claim 3, wherein the fourth stent section defines the at leastpartially conical body when only partially deployed and devise at leastpartially cylindrical body when in a deployed state.
 21. The replacementvalve of claim 3, wherein the second stent section is configured tocreate a form fit with an outflow tract and native leaflets of an aorticvalve and thus prevent migration of the stent component and the valvecomponent towards the left ventricle.